Motor and Cognitive Telerehabilitation in a Virtual Environment in Patients With Post-stroke Sequelae and Parkinson's Disease

Sponsor
Azienda Usl di Bologna
Study ID
NCT07582497
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VR-based Telerehabilitation with Home Kit — OTHER
    The proposed intervention uses a certified Home Kit - inclusive of an immersive VR headset - already employed in clinical practice at the coordinating center (IRCCS ISNB, Bologna). The rehabilitation team (physician, speech therapist, physiotherapist) defines an individualized protocol for cognitive and/or motor recovery. The first 3 sessions are conducted in-person to allow technology familiarization. Patients then use the Home Kit at home for 50 minutes/day, 5 days/week, for 4 weeks, in asynchronous mode. One weekly synchronous session via videoconference with the therapist is included. The Home Kit automatically records daily protocol execution, enabling continuous telemonitoring and timely adaptation of rehabilitation parameters.
  • Standard Rehabilitation (Conventional Care) — OTHER
    Patients in the control group receive cognitive and/or motor rehabilitation according to standard clinical practice, as defined by the individual rehabilitation project. Sessions last 50 minutes, are delivered 5 days per week, for 4 weeks, and are conducted in person at the rehabilitation unit. No virtual reality or telerehabilitation technology is used in this arm.

Study Details

The goal of this interventional pilot trial is to evaluate whether a telerehabilitation protocol based on immersive virtual reality (VR) is effective and feasible for the recovery of cognitive and/or motor functions in patients with sequelae of ischemic or hemorrhagic stroke or with Parkinson's disease. The main questions it aims to answer are: * Does the VR-based telerehabilitation protocol improve cognitive and/or motor outcomes compared to conventional rehabilitation? * Is the protocol feasible, defined as ≥80% adherence among participants? Is the system acceptable and user-friendly from the patient's perspective? Researchers will compare an interventional arm receiving telerehabilitation via an immersive VR home kit with a control arm receiving conventional rehabilitation according to standard clinical practice. Both groups will receive the same number of sessions, with the same duration and weekly frequency. Outcomes will be assessed at baseline (T0), after 4 weeks of treatment (T1), and at 3-month follow-up (T2).

Key Dates

First listed
May 13, 2026
Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Jul 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Telerehabilitation with Immersive Virtual Reality (TR Group)
    Patients will receive an individualized cognitive and/or motor rehabilitation protocol via a certified Home Kit inclusive of an immersive VR headset. After 3 in-person familiarization sessions, patients will perform the rehabilitation program at home for 50 minutes/day, 5 days/week, for 4 weeks, in asynchronous mode with one weekly synchronous videoconference session with the therapist. Continuous telemonitoring and parameter adaptation will be provided throughout the treatment period.
  • Active Comparator: Conventional Rehabilitation (Control Group)
    Patients will receive cognitive and/or motor rehabilitation according to standard clinical practice, consisting of individual rehabilitation sessions of 50 minutes, 5 days per week, for 4 weeks, as defined by the individual rehabilitation project.

Primary Outcome Measure

Adherence rate to the telerehabilitation protocol [ Time Frame: End of treatment (T1, Week 4) ]

Central Contacts

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